FDA-Device2026-07-08Class IIPROCESSING DEFECT
Siemens ARTIS icono biplane recalled for potential loss of movement after detector adjustment
What this means
Siemens Medical Solutions USA is recalling certain ARTIS icono biplane X-ray systems (Model 11327600) because the detector lift height may stop moving when adjusted to its maximum or minimum limits. This could prevent the equipment from operating normally during medical imaging procedures.
- If you operate this equipment, contact Siemens Medical Solutions USA immediately for service instructions.
- Do not adjust the detector lift height to maximum or minimum limits until the equipment has been serviced.
- Check if your facility's serial number is listed in the recall notice.
The agency's original wording
Hazard
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
85 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
ARTIS icono biplane. Model Number: 11327600.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2641-2026More Siemens recalls
- FDA-Device2026-07-08Siemens ARTIS icono ceiling model 11328100 recalled for loss of movement capability
- FDA-Device2026-07-08Siemens ARTIS icono floor recalled for potential movement loss at detector height limits
- FDA-Device2026-07-08Siemens ARTIS icono ceiling monitor suspension recalled for loose screw risk
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